One of the bigger healthcare stories of the past month has been the FDA's accelerated approval of aducanumab (Aduhelm). See the FDA's page for data, decision analysis, and labeling here. Aduhelm was shown to reduce beta-amyloid levels in Alzheimer patients, which was also statistically associated with better cognitive function in the trial data.
However, over the past several days, several BCBS plans have posted noncoverage positions (see one here). (July 13: Update here.) Concurrently, to quote an alert published by the group Washington Analysis LLC in a new bulletin, the health insurance organization AHIP has requested that CMS develop a National Coverage Determination for Aduhelm (here). (Note that the most recent major NCD for drugs/biologicals was for CAR-T therapies, following an external request from United Healthcare.)
Alzheimer Association has also issued a press release asking for CED, here.
A recent blog at Health Affairs by Chambers, Lin, Tunis, and Neumann suggested that a Medicare NCD with "coverage with evidence development" might be possible - here. CMS has a website for pending NCDs (aka "NCD Wait List") here, but hasn't updated it since September 2020, approaching a year.
According to BioPharmaDive, quoting the FDA calendar, Peter Stein and Jacqueline Curay of FDA met with Alfred Sandrock and Michael Vounatsos of Biogen on June 14. BioPharmaDive also notes the AHIP letter to CMS.
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CED was also raised by authors at Pink Sheet and Forbes. It is mentioned in the AHIP letter (p.3).
